FDA 510(k) Applications Submitted by RAYMOND KELLY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090182 |
01/26/2009 |
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) |
NUCLEMED S.A. |
| K090190 |
01/26/2009 |
WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM |
NUCLEMED S.A. |
| K110282 |
01/31/2011 |
LIGHTY DD INFUSION SET |
MEDX-SET LTD |
| K140386 |
02/14/2014 |
LUMINA 24 |
ROGERS SCIENCES INC. |
| K141002 |
04/18/2014 |
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
Visionsense Ltd. |
| K111226 |
05/02/2011 |
ENDOSCOUT TRACKING SYSTEM |
ROBIN MEDICAL, INC. |
| K101401 |
05/18/2010 |
NEUMOVENT GRAPHNET MODEL 3179L1V |
TECME S.A. |
| K131557 |
05/29/2013 |
RITTER IMPLANT SYSTEM |
RITTER IMPLANTS GMBH CO KG |
| K201616 |
06/15/2020 |
SyMRI |
SyntheticMR AB |
| K121812 |
06/20/2012 |
SONIXGPS |
UltraSonix Medical Corporation |
| K101839 |
07/01/2010 |
KANEKA PHARMA AMERICA XPRESS-WAY RX |
KANEKA PHARMA AMERICA LLC |
| K162862 |
10/12/2016 |
Raycast High Precision Lung Board Solution |
Orfit Industries NV |
| K073092 |
11/01/2007 |
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, |
SPIRE BIOMEDICAL INC |
| K073093 |
11/01/2007 |
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, |
SPIRE BIOMEDICAL INC |
| K093431 |
11/04/2009 |
CLEARWAY OTW MODEL 85912 |
ATRIUM MEDICAL CORP. |
| K103346 |
11/15/2010 |
DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY |
SHERPA KOREA |
| K110110 |
01/14/2011 |
ATRIUM CENTRILFX MESH |
ATRIUM MEDICAL CORPORATION |
| K150219 |
01/30/2015 |
Equashield Closed System drug Transfer Device (CSTD) |
EQUASHIELD MEDICAL LTD |
| K131144 |
04/23/2013 |
AMECO SHEATH INTRODUCER |
AMECO MEDICAL INDUSTRIES |
| K102596 |
09/09/2010 |
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT |
ATRIUM MEDICAL CORP. |
| K133222 |
10/18/2013 |
SAAD PATIENT MONITOR (SPM) |
HANIN MEDICAL SERVICES CO. LTD |
| K130424 |
02/20/2013 |
STIMEL-03 |
STIMEL LTD |
| K100595 |
03/02/2010 |
ECLERIS MICROSTAR COLPOSCOPE |
Ecleris USA |
| K131045 |
04/15/2013 |
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE |
CARDIAC DESIGNS, LLC |
| K131323 |
05/08/2013 |
ECLERIS SINUSCOPE |
Ecleris USA |
| K132899 |
09/16/2013 |
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) |
EQUASHIELD MEDICAL LTD |
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